BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 503232 · Received December 30, 2003

    Report

    Report Number
    503232
    Event Type
    Malfunction
    Date Received
    December 30, 2003
    Date of Event
    September 1, 2003
    Report Date
    September 1, 2003
    Manufacturer
    BURTON MEDICAL PRODUCTS, INC.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMOKE EMITTED FROM THE ELBOW OF THE EXTENSION ARM. THE INTERNAL 3 AMP FUSE DID NOT BLOW. INTERNAL WIRES WERE BURNED IN TWO PLACES AS DESCRIBED BELOW: WIRES INSIDE THE ARM PIECE NEAR THE MOLEX CONNECTORS; INSIDE THE BASE NEAR THE TRANSFORMER. ORANGE AND BROWN WIRES FROM THE TRANSFORMER BURNED AS WELL AS THE ORANGE AND RED WIRES FROM THE WIRE HARNESS COMING FROM THE ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SURGICAL LIGHT FSY BURTON MEDICAL PRODUCTS, INC. 0244310 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other